Pfizer Inc. (PFE) and Astellas Pharma Inc. (ALPMY) Thursday said Phase 3 EMBARK study of XTANDI for the treatment of prostate cancer met its primary goal.
EMBARK study enrolled 1,068 patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) and high-risk biochemical recurrence (BCR). They were randomized to one of three study arms- XTANDI plus leuprolide, placebo plus leuprolide, or XTANDI monotherapy.
Topline results from the study showed that XTANDI plus leuprolide significantly improved metastasis-free survival in men with non-metastatic prostate cancer, Astellas said.
"The topline findings from EMBARK are highly encouraging and we look forward to engaging with health authorities to potentially bring XTANDI to men with non-metastatic hormone sensitive prostate cancer and high-risk biochemical recurrence." said Chris Boshoff, Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development.
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